Date: 2012-04-26

Type of information: Commercialisation agreement

Compound: ConfirmMDx™ for Prostate Cancer

Company: MDxHealth (Belgium) PLUS Diagnostics (USA)

Therapeutic area: Cancer - Oncology

Type agreement:


Action mechanism:

ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment. The test is able to detect a proven epigenetic field effect or “halo” associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular “halo” around a cancer lesion can be present despite having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying men who may safely forego unnecessary repeat biopsies.

Disease: prostate cancer


MDxHealth, a molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, and PLUS Diagnostics have entered into an agreement to co-promote MDxHealth’s ConfirmMDx™ for Prostate Cancer test in the United States. PLUS Diagnostics, a leading U.S. anatomic pathology company that offers a full range of multi- specialty services, will build awareness of ConfirmMDx for Prostate Cancer, through its national network of urologists. ConfirmMDx for Prostate Cancer is a laboratory-developed test (LDT), performed at MDxHealth’s Irvine, California laboratory that assists urologists with identifying men who may safely forego unnecessary repeat biopsies.
MDX Health expects to launch ConfirmMDx for Prostate Cancer in Q2 2012. MDxHealth and PLUS Diagnostics will begin co-promoting the test immediately.

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Is general: Yes